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510(k) K041783

POLAR WAND by Chek-Med Systems — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2004
Date Received
July 1, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Chek-Med Systems

  • K021387 — POLAR WAND (July 31, 2002)
  • K993951 — SPOT ENDOSCOPIC MARKER (February 18, 2000)

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